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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAKREOS POSTERIOR CHAMBER INTRACULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP060022
Supplement NumberS008
Date Received03/18/2011
Decision Date04/29/2011
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO IMPLEMENT THE PROPOSED CHANGE TO THE BIOBURDEN TESTING FOR THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS.
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